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Quartal 2000 I.V.
Mycophenolate Mofetil (MMF) in the Prophylaxis of Acute GvHD in Stem
Cell Transplant Recipients Despite immunosuppressive prophylaxis with cyclosporin A (CSA), prednisolone and methotrexat (MTX) the incidence reported for grade II-IV aGvHD after HLA-matched unrelated donor transplantation (MUD-HSCT) is 78% and the incidence for grade III-IV is 36%. Since GvHD is a major contributor to morbidity and mortality after MUD BMT, more efficient prophylactic regimes are urgently warranted in order to prevent these complications. We herein report results of a pilot study of i.v. MMF in the prophylaxis of GvHD in HSCT recipients: 17 pts. (12m/5w), median age 38y, with diagnoses of AML (6), ALL (2), MDS (2), CML (6), and ß-Thalassemia (1) received a prophylactic regime of MMF 1g bid, CSA (plasma levels 250-300 µg/l) and prednisolone (1mg/kg BW +14 - +28, then tapered) and were analyzed in comparison to historical controls matched for age, sex, disease, transplant and HLA-compatibility, which had received MTX prophylaxis instead of MMF. There were no severe adverse events associated with MMF and no episode of graft-failure was noticed. We have observed a clear reduction of severe GvHD grade II to IV (p=0.19) as well as a significant reduction of severe mucositis grade III + IV (0/17 vs. 5/17, p=0.035) in the MMF group. Pharmacokinetic studies showed no signs of accumulation of the active drug metabolites and we do not observe a clear dose-response relation. MMF seems to be save and in an ongoing prospective multicenter randomized trial we try to define its role in GvHD prophylaxis. Key words: Mycophenolat mofetil (MMF), GvHD, treatment, prophylaxis, i.v. application PD Dr. M. G. Kiehl
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